A kind of novel interventional medical device
Technical field
The present invention relates to a kind of interventional medical device.
Background technology
Interventional therapy is the important means of the arteries disease treatment that grows up nearly three more than ten years.Balloon expanding technology has appearred in the seventies in last century, and it is under the guiding of medical imaging device, foley's tube is inserted the narrow positions of blood vessel with the percutaneous puncture technology, under the strictness monitoring, carry out balloon expandable and expand, make the narrow positions of blood vessel obtain expansion, thereby recover lumen diameter.Though sacculus can be eliminated the narrow of blood vessel, owing to blood vessel elasticity retraction, cells of vascular wall hypertrophy and the tunica intima of expansion such as tear at reason, the incidence rate of operation vascular restenosis reaches 30%~50%.The eighties in last century, naked metal rack comes out, and tears by repairing inner membrance, and the incidence rate of vascular restenosis reduces, but still about 30%.At the beginning of 21 century, bracket for eluting medicament drops into clinical practice, and drug slow discharges can inhibition of cell proliferation, and the restenosis incidence rate is reduced to about 5% in the blood vessel.Though the in-stent restenosis incidence rate of bracket for eluting medicament significantly descends, it also has some defectives.Along with the prolongation of time, the use of bracket for eluting medicament may increase advanced thrombus and form.In addition, after the bracket for eluting medicament implantable intravascular, need take the treatment of aspirin and clopidogrel, the two all has certain hemorrhage risk.
No matter be balloon expandable operation, or the support implantation surgery, all can to a certain degree cause side effect, as inflammation, tunica intima tear, vascular cell hypertrophy etc., thereby cause vascular restenosis.Therefore, need carry certain anti-inflammatory, cell proliferation medicine to lesion vessels.Oral or medicine injection is the most frequently used method, though it has certain effect to suppressing vascular restenosis, normal blood vessels is had very large side effect.And realization will be a kind of simple, quick and effective method to the administration in time of lesion vessels expansion back.But also there is not such effective method in prior art.
Summary of the invention
Above-mentioned technical problem in view of prior art, the objective of the invention is to develop a kind of novel interventional medical device, it can overcome the unicity of existing sacculus dilating catheter function, narrow positions in the not only expansible blood vessel, can also in time carry medicine simultaneously to the blood vessel after the expansion, thereby repair the damage of blood vessel endothelium, the hypertrophy of inhibition smooth muscle cell, prevent vascular restenosis, and can prevent the injury of medicine normal blood vessels.
For achieving the above object, the invention provides a kind of interventional medical device, this interventional medical device comprises sacculus, conduit and connecting device, and described conduit couples together described sacculus and described connecting device, it is characterized in that:
Described conduit is four lumens, has four cavitys in the inside of this four lumen, i.e. guidewire lumen, expansion cavity, separate cavities and loading chamber, and wherein said guidewire lumen runs through whole described conduit;
Distal portion at this four lumen is provided with three described sacculus, be distal balloon catheter, middle sacculus and proximal balloon, wherein said distal balloon catheter can be communicated with described connecting device by described separate cavities with described proximal balloon, sacculus can be communicated with described connecting device by described expansion cavity in the middle of described, form the temporary stopping chamber thereby described distal balloon catheter and described proximal balloon can stop blood flow in operation process, described middle sacculus then can play dilating effect; And above-mentioned temporary stopping chamber can also be communicated with described connecting device by described loading chamber.
Preferably, described guidewire lumen is that internal diameter is the circular cavity of 0.1mm-1.2mm.
Preferably, there is groove in described expansion cavity in the position relative with described middle sacculus, so that be communicated with described middle sacculus; There is groove respectively in described separate cavities in the position relative with described distal balloon catheter and described proximal balloon, so that be communicated with described distal balloon catheter and described proximal balloon respectively; And there is groove respectively in described loading chamber at gap location between described distal balloon catheter and the described middle sacculus and the gap location between described proximal balloon and described middle sacculus, so that be in communication with the outside.Described expansion cavity, described separate cavities and described loading chamber can be designed to different shape, to satisfy various application demands.
Preferably, described connecting device is the five-way adapter that has four female Luer, and described four female Luer are communicated with guidewire lumen, expansion cavity, separate cavities and loading chamber in described four lumens respectively; Described guidewire lumen is used at operation process by seal wire or detect intraluminal pressure; Described expansion cavity be used to apply make described in the middle of sacculus expansible pressure; Medicine not only can be carried in described loading chamber in above-mentioned temporary stopping chamber, can also be after operation be finished the pumpback medicine.Herein, by in above-mentioned temporary stopping chamber, carrying medicine, can be to the lesion vessels target administration; And, can reduce the side effect of medicine to normal blood vessels by pumpback medicine after finishing in operation.
Preferably, described distal balloon catheter and proximal balloon adopt the compliance medical macromolecular materials, and these compliance medical macromolecular materials comprise silicone rubber, polyurethane and latex, and the working pressure range of described distal balloon catheter and proximal balloon is 1-5atm.
Preferably, sacculus adopts non-compliance or low compliance medical macromolecular materials in the middle of described, this non-compliance or low compliance medical macromolecular materials comprise polyamide-based macromolecular material, modified polyamide macromolecular material and polymer composite, and the working pressure range of described middle sacculus is 6-20atm.
Preferably, described interventional medical device further comprises the development labelling, and described development labelling is embedded in or is enclosed within on described four lumens, and the position of described development labelling is relative with the position of described distal balloon catheter, described middle sacculus and described proximal balloon.
In the actual operation process, the operating procedure of interventional medical device of the present invention is as follows:
1). by the conduit and the seal wire of this interventional medical device of guiding, foley's tube is sent into diseased region during use; 2). in expansion cavity, inject contrast solution, fill middle sacculus to expand narrow blood vessel, then the pumpback contrast solution; 3). in separate cavities, inject contrast solution with full device, distal balloon catheter and proximal balloon be expanded to can stop blood flow, thereby form one temporary " chamber "; 4). inject gene or medicine in the loading chamber, gene or medicine pass the loading chamber and enter above-mentioned " chamber " and act on lesion vessels; 5) in expansion cavity, inject contrast solution, balloon expandable in the middle of making, and by loading chamber pumpback medicine; 6). by the contrast solution in separate cavities pumpback distal balloon catheter and the proximal balloon, the contrast solution in the sacculus in the middle of the pumpback is then withdrawn from the conduit of this interventional medical device externally at last, and treatment is promptly accused and finished.
Interventional medical device of the present invention can be used for treating narrow disease in the blood vessel, and it has following beneficial effect:
(1) narrow positions in the not only expansible blood vessel of novel interventional medical device of the present invention can also in time be carried medicine to the blood-vessels target after the expansion simultaneously, and can be removed unnecessary medicine in the blood vessel, reduces the side effect of postoperative medicine to normal blood vessels; And this interventional medical device just can be withdrawn from external after operation is finished, and has avoided the cohesion of blood at diseased region, thereby reduces the probability of restenosis.And this interventional medical device with regard to solving the diffuse lesion of same blood vessel, greatly reduces surgery cost by same conduit.
(2) interventional medical device provided by the invention need not by any polymer and additional coatings with regard to releasable medicaments, and liquid medicine can pass slit and crack in the speckle, medicine is fully contacted with tube wall, and can reduce damage, thereby reach best curative effect blood vessel.
Description of drawings
In order to be illustrated more clearly in the technical scheme of the embodiment of the invention, the accompanying drawing of required use is done to introduce simply in will describing embodiment below.It is evident that the accompanying drawing in describing below only is the specific embodiment of putting down in writing among the application, it is not the restriction to protection scope of the present invention.For those of ordinary skills, under the prerequisite of not paying creative work, can also obtain some other embodiment and accompanying drawing according to following embodiment of the present invention and accompanying drawing thereof certainly.
Fig. 1 is a kind of structural representation of interventional medical device according to an embodiment of the invention.
Fig. 2 is the profile of four lumens of interventional medical device according to an embodiment of the invention.
Fig. 3 is the forward enlarged diagram of interventional medical device according to an embodiment of the invention.
The specific embodiment
In order to make those skilled in the art person understand technical scheme among the application better,, the technical scheme in the embodiment of the invention is clearly and completely described below in conjunction with the accompanying drawing in the embodiment of the invention.Obviously, described embodiment only is the application's part embodiment, rather than whole embodiment.Based on the described specific embodiment of the application, all other embodiment that those of ordinary skills are obtained under the prerequisite of not making creative work should drop within the design scope of the present invention.
Describe the preferred embodiments of the present invention in detail below with reference to accompanying drawing.
Fig. 1 is a kind of structural representation of interventional medical device according to an embodiment of the invention.
As shown in Figure 1, this novel interventional medical device comprises: sacculus 1, four lumens 2, connecting device 3 and development labelling 4, wherein be provided with three sacculus in the front portion of this interventional medical device, these three sacculus are respectively distal balloon catheter 1-1, middle sacculus 1-2 and proximal balloon 1-3, wherein distal balloon catheter 1-1 and proximal balloon 1-3 can stop blood flow to pass through in operation process, thus can form one temporary " chamber "; And middle sacculus 1-2 can play dilating effect.
Fig. 2 is the profile of four lumens 2 of interventional medical device according to an embodiment of the invention.As shown in Figure 2, there are four cavitys in the inside of described four lumens 2, and it is respectively guidewire lumen 2-1, expansion cavity 2-2, separate cavities 2-3 and loading chamber 2-4; Wherein, described guidewire lumen 2-1 runs through the whole conduit of four lumens 2.
Fig. 3 is the forward enlarged diagram of interventional medical device according to an embodiment of the invention.Shown in the enlarged diagram of Fig. 3, there is groove in the expansion cavity 2-2 of described four lumens 2 in the position relative with described middle sacculus 1-2, thereby can make described expansion cavity 2-2 be connected with middle sacculus 1-2.There is groove in described separate cavities 2-3 in the position relative with described distal balloon catheter 1-1 and proximal balloon 1-3 respectively, thereby can make described separate cavities 2-3 be connected with distal balloon catheter 1-1 and proximal balloon 1-3.There is groove in described loading chamber 2-4 at gap location between distal balloon catheter 1-1 and the middle sacculus 1-2 and the gap location between proximal balloon 1-3 and middle sacculus 1-2, thereby can be connected with the external world.
Described connecting device 3 is for having the five-way adapter of four female Luer, and described four female Luer are interface 3-1,3-2,3-3,3-4, and they are communicated with guidewire lumen 2-1, expansion cavity 2-2, separate cavities 2-3 and loading chamber 2-4 respectively.Described guidewire lumen 2-1 leads to the distal end of catheter of described four lumens 2, is used for operation process by seal wire or detect intraluminal pressure; Sacculus 1-2 was used to apply the pressure that makes inflation in the middle of described expansion cavity 2-2 led to; Described separate cavities 2-3 leads to the distal balloon catheter 1-1 and the proximal balloon 1-3 at the anterior place of conduit of described four lumens 2, so that distal balloon catheter 1-1 and proximal balloon 1-3 expand and blocking blood flow, and then forms airtight " chamber "; Described loading chamber 2-4 not only can carry medicine in above-mentioned " chamber ", and then to the lesion vessels target administration, also can be after operation be finished the pumpback medicine, to reduce the side effect of medicine to normal blood vessels.
Described distal balloon catheter 1-1 and proximal balloon 1-3 adopt the compliance medical macromolecular materials, and as silicone rubber, polyurethane, latex etc., the working pressure range of described distal balloon catheter 1-1 and proximal balloon 1-3 is 1-5atm; Sacculus 1-2 adopts non-compliance or low compliance medical macromolecular materials in the middle of described, and as polyamide-based macromolecular material, modified polyamide macromolecular material or polymer composite, the working pressure range of described middle sacculus 1-2 is 6-20atm.
On the tube wall of four lumens 2 of middle sacculus 1-2 inside, be embedded with two development labellings 4.On the tube wall of four lumens 2 of distal balloon catheter 1-1 and proximal balloon 1-3 inside, respectively be embedded with 1 development labelling 4.The effect of development labelling 4 is to show that when operation sacculus 1 is in the intravital position of people.
The invention provides a kind of novel interventional medical device, it can be used for treating narrow disease in the blood vessel.When using this interventional medical device to carry out intervene operation, the doctor at first pierces into seal wire in the blood vessel, after arriving lesion vessels, again the far-end of seal wire end by the guidewire lumen 2-1 of four lumens 2 of this interventional medical device pierced in four lumens 2, and from the interface 3-1 of connecting device 3, pass, along seal wire sacculus 1 being pushed to the vascular lesion position, can come out by the position display of development labelling 4 under the X-ray in the position of sacculus 1; After sacculus 1 arrives the vascular lesion place, inject contrast solution to the interface 3-2 of connecting device 3, contrast solution fills middle sacculus 1-2 to expand narrow blood vessel by expansion cavity 2-2, then the pumpback contrast solution; Inject contrast solution with full device to the interface 3-3 of connecting device 3, contrast solution makes distal balloon catheter 1-1 and proximal balloon 1-3 be expanded to the degree that can stop blood flow by separate cavities 2-3, to form one temporary " chamber "; Interface 3-4 by connecting device 3 injects gene or medicine in the 2-4 of loading chamber, gene or medicine pass loading chamber 2-4 enter above-mentioned " chamber " thus act on lesion vessels; Interface 3-2 by connecting device 3 injects contrast solution in expansion cavity 2-2, so that middle sacculus 1-2 expansion, and the interface 3-4 pumpback medicine by connecting device 3; By the interface 3-3 pumpback distal balloon catheter 1-1 of connecting device 3 and the contrast solution among the proximal balloon 1-3, the contrast solution among the sacculus 1-2 in the middle of the pumpback is then withdrawn from the conduit of this interventional medical device externally at last, and treatment is promptly accused and finished.
According to interventional medical device of the present invention, not only expansible endovascular narrow positions can also in time be carried medicine to the blood-vessels target after the expansion simultaneously, and can be removed unnecessary medicine in the blood vessel, reduces the side effect of postoperative medicine to normal blood vessels; And this interventional medical device is just withdrawn from external after operation is finished, and has avoided the cohesion of blood at diseased region, thereby reduces the probability of restenosis.And this interventional medical device with regard to solving the diffuse lesion of same blood vessel, greatly reduces surgery cost by same conduit.And the interventional medical device that the embodiment of the invention provides need not by any polymer and additional coatings with regard to releasable medicaments, and liquid medicine can pass slit and crack in the speckle, medicine is fully contacted with tube wall, and can reduce damage, thereby reach best curative effect blood vessel.
The above only is the application's a preferred embodiment.Should be understood that; for those skilled in the art; under the prerequisite that does not break away from the present application principle and inventive concept, can also make some improvement and modification, these improve and modification also should be considered as dropping within the application's the protection domain and inventive concept.